MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. CLINIXT SYSTEM; SYSTEM, X-RAY, STATIONARY

Model Number 70441

Device Problem Detachment Of Device Component (1104)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

The customer reported that while performing a patient chest exam at the wall bucky, the collimator came loose on the x-ray tube and fell off the tube mount, striking the operator in the groin.A philips field service engineer (fse) confirmed that the operator received an onsite medical examination and was cleared of internal injury, but complained of severe pain.The fse inspected the x-ray system and confirmed that the collimator was hanging from the x-ray tube by a single control cable.The fse replaced the collimator and bolts to resolve the issue.

Manufacturer Narrative

(b)(4).Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).

Manufacturer Narrative

On 13-may-2015, the customer reported that while performing a patient chest exam at the wall bucky, the collimator came loose on the x-ray tube and fell off the tube mount, striking the operator in the groin.A philips field service engineer (fse) confirmed that the operator was struck in the groin and received an onsite medical examination and was cleared of injury.On 13-may-2015, the fse arrived on site and evaluated the system.The fse noted that there were no known problems with the collimator before this event or any work performed on the collimator.Upon arrival and evaluation, the fse reported that when he examined the collimator¿s swivel mount and mounting screws, there was no apparent damage or indication of mechanical failure.The fse reported that the four screws that hold the collimator to the swivel mount backed out allowing the collimator to fall.The fse replaced the collimator and the swivel mount collimator bolts.There have not been any further recurrences of this issue at the site.No log files or bug reports were provided for engineering assessment; therefore, an engineering evaluation could not be made.No failure analysis of the part could be performed because the collimator unit was scrapped after replacement.The system is operational.

• Brand Name: CLINIXT SYSTEM
• Type of Device: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.; 595 miner rd; cleveland OH 44143
• Manufacturer Contact: nancy drake ; 595 miner rd; cleveland, OH 44143 ; 4404833000
• MDR Report Key: 4835939
• MDR Text Key: 5941595
• Report Number: 1525965-2015-00162
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 70441
• Device Catalogue Number: 70441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 100